复方白及液微生物限度检查方法适用性研究

目的:对复方白及液微生物限度检查方法适用性进行研究,建立该产品的微生物限度检查方法.方法:按照《中国药典》2020年版要求,分别采用培养基倾注法、薄膜过滤法,进行微生物计数方法适用性试验.采用常规法、薄膜过滤法、培养基稀释法进行控制菌检查方法适用性试验.结果:微生物计数方面,培养基倾注法不能满足要求,采用薄膜过滤法,需...

Study on Suitability of Microbial Limit Test Method of Compound Baiji Enema

Objective:To establish the microbial limit test method of Compound Baiji Enema,the suitability of microbial limit test method was studied.Methods:Accordingto ChP2020,The plate pouring method and the membrane filtration method were used for the tests of total count(aerobic microbial,yeasts and molds).The direct inoculation method,the membrane filtration and the medium dilution method were used for the detection of control bacteria test.Results:The plate pouring method couldn′t met the requirement of the recovery ratio.Using membrane filtration method,the recovery ratio of validation strains was in 0.5~2.In control bacteria test,S.aureus was determined by membrane filtration method and medium dilution method,P.aeruginosa can be determined by the medium dilution method.Conclusion:The membrane filtration and medium dilution method were used to remove the antimicrobial activity,that was suitable for the microbial limit test method of Compound Baiji Enema.